FDA OKs Fresenius Kabi’s Adaptive Nomogram for Plasma Collection

Fresenius Kabi has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Adaptive Nomogram, an alternative algorithm in the Aurora Xi plasmapheresis system that was designed to optimize plasma collection efficiency.

The system consists of the Aurora Xi instrument and a Plasmacell Xi disposable set. The automated plasmapheresis system is intended for source plasma collections.

Whole blood is drawn from the donor and plasma is separated from concentrated cells using a rapidly rotating membrane filter. Plasma is collected in a container and residual cellular components are returned to the donor.

Adaptive Nomogram considers individual donor characteristics in calculating the volume of plasma to collect. According to the company, this allows an average 11.5% increase in collection per donation.

Plasma-derived therapies are essential for treating a wide range of conditions, including immune deficiencies, bleeding disorders, and neurological diseases.

“This FDA clearance marks a significant step forward for Fresenius Kabi in advancing the efficiency and sustainability of plasma collection,” said Dr. Christian Hauer, President, MedTech at Fresenius Kabi. “The Adaptive Nomogram represents a breakthrough in donor experience innovation, leveraging donor data to deliver one of the most personalized and optimized plasma collection processes available today.”

Data supporting Adaptive Nomogram’s FDA nod

A multicenter, prospective randomized controlled clinical trial was conducted to evaluate the Adaptive Nomogram in Aurora Xi Software Version 2.0 compared to Aurora Xi with the existing Optimized Nomogram. The trial entailed over 52,400 procedures at three of Takeda’s BioLife Plasma donation centers.

The primary endpoint—to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi Adaptive Nomogram algorithm was under double the SHAE rate in donors using the Aurora Xi Optimized Nomogram algorithm—was met. The trial also showed the Adaptive Nomogram increased the volume of plasma collected per completed donation by an average of 88.0 mL (11.5%, plasma without anticoagulant) while increasing procedure time an average of 3 minutes 37 seconds (9.7%).

“This new Adaptive Nomogram will help us personalize each plasma donation and improve our efficiency, while our organization continues to safeguard the health of our donors,” said Hema Tallman, Global Head of BioLife Plasma Services at Takeda. “We were grateful for the opportunity to collaborate with Fresenius Kabi on the clinical trial, and we look forward to being the first company to introduce it in our plasma donation centers in the coming months.”